FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan

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					FDA Approves Opioid Pain Reliever with Required
Risk Reduction Plan
       he U.S. Food and Drug                   this reason, Onsolis should be prescribed      should not be substituted for other

T      Administration in July approved
       Onsolis, a medication intended for
certain patients with cancer to help
                                               only under the safeguards provided by
                                               the FDA-required REMS and by health-
                                               care professionals knowledgeable about
                                                                                              fentanyl products.
                                                                                                  In February, the FDA announced that
                                                                                              it would require a REMS for a different
manage breakthrough pain—severe flares         Onsolis and the use of potent opioid           class of opioids that offer long-acting and
of pain that break through regular pain        medications.”                                  extended-release medication. The FDA
medication.                                        The Food and Drug Administration           has held a series of meetings with stake-
    Onsolis is in a class of drugs that        Amendments Act of 2007 gave the FDA            holders, including a large public meeting,
deliver the potent opioid fentanyl             the authority to require that drugs and        and also solicited written public
through the mouth’s mucous membranes.          biological products have a REMS to             comments to hear more about how to
Onsolis delivers fentanyl via an               ensure that the benefits of a drug or          develop this REMS.
absorbable film that sticks to the inside of   biological product outweigh its risks.             “The REMS for Onsolis was specifically
the cheek. The drug is indicated for the           As part of the REMS, Onsolis will only     tailored to that drug and should not be
management of breakthrough pain in             be available through a restricted distribu-    viewed as a model REMS for long-acting
patients with cancer, ages 18 and older,       tion program called the FOCUS program.         and extended-release opioid products,”
who already use opioid pain medication         Under this program, only those prescribers,    said Douglas Throckmorton, MD, deputy
around the clock and who need and are          patients, and pharmacies registered with       director of CDER. “Developing the com
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